Various medical procedures attach wire-like devices to internal portions of a person's body, such as an electrical lead for a pacemaker or a catheter. Pacemaker leads are electrically conducting wires which run to an electrode that is attached to an inner wall of a person's heart. Pacemaker leads are typically a coil of wire enclosed in an outer cylindrical sheath of electrically insulating material. The coil of wire usually leaves a hollow space running down the center of the pacing lead (a “lumen”).
Pacing leads are usually implanted with the intention that they will remain in the patient for several years. During such time, fibrous tissue grows over the electrode and portions of the lead. Pacing leads are often provided with additional barb-like structures or a corkscrew type of structure to encourage adhesion to the inner wall of the patient's heart.
Pacing leads sometimes fail or it is sometimes desirable to place an electrode at a different position from a previous position. It is then necessary to determine what should be done with the unused pacing leads. Both the removal of a pacing lead and leaving it in the patient entail associated risks. Leaving the pacing lead in the patient can increase the chances of infection, interfere with the additional pacing leads, or cause additional complications. On the other hand, removing pacing leads can cause severe, and possibly fatal, damage to the patient's heart.
Numerous devices have thus been developed that can be inserted into the lumen of a pacing lead and attach to the pacing lead close to the electrode in order to apply traction to the end of the lead close to the electrode. A series of patents to Goode et al. (U.S. Pat. Nos. 4,943,289; 4,988,347; 5,011,482; 5,013,310; and 5,207,683) disclose various devices which attach to the pacing lead at a localized region close to the electrode. Peers-Trevarton (U.S. Pat. No. 4,574,800), Hocherl et al. (U.S. Pat. No. 5,549,615), and McCorkle (U.S. Pat. Nos. 4,471,777 and 4,582,056) disclose similar devices which attach to a pacing lead close to the electrode. However, all of these devices have a disadvantage that they attach to the pacing lead in a localized area. Applying traction to the pacing lead and/or pacing lead removing devices according to the prior art can lead to the pacing lead's becoming distorted and/or breaking before the pacing lead is successfully removed from the patient. In addition, the prior art devices rely on either a form of entanglement with the coiled wire of the pacing lead, or some form of local distortion to the coil of the pacing lead in order to maintain a firm grip with the pacing lead removing apparatus while traction is applied to the apparatus. Consequently, this makes it difficult or impossible to remove a conventional device from the pacing lead in order to abort or restart the pacing lead removing procedure.
The expandable portions of the conventional devices also make it difficult or impossible to use other lead removing equipment and procedures in conjunction with those devices. For example, a substantially cylindrical and flexible catheter which has a central lumen is often slid over the pacing lead such that the pacing lead passes through the lumen of the catheter and the leading edge of the catheter is used to free fibrous growth from the pacing lead. Laser catheters are also known to slide over a pacing lead in which laser light is transmitted along the catheter in order to cut away fibrous tissue as the laser catheter is advanced along the pacing lead. Consequently, it is also desirable to have a pacing lead removing device which can attach internally to the pacing lead so as not to obstruct a catheter or laser catheter which may be used in conjunction with the pacing lead removing device.
Lead-locking devices are disclosed in related U.S. Pat. Nos. 6,167,315, 6,324,434, and 6,772,014, by Coe, et al., which are each fully incorporated herein by reference. In some embodiments, the devices of Coe are built around a core mandrel having a distal region featuring a first diameter, around which a metal braid or other elastic material is disposed. The distal end of the metal braid is bonded to the mandrel near the distal end of the mandrel. The proximal region of the mandrel has a larger diameter than the distal region; a tapered section connects the distal and proximal regions. The device is deployed into the inner lumen of a lead while the metal braid is stretched tightly over the mandrel. Once inserted, the proximal end of the braid is loosened, allowing the braid to expand radially. As the diameter of the braid increases, the braid engages the inner lumen of the lead essentially along the entire length of the lead.
While the devices disclosed in Coe are suitable for intended purposes, in some limited situations, such as with some pacing leads in tortuous anatomy, such a device might tend to catch on inner coils of the pacing lead. Thus, an unmet need remains for a lead locking device with improved tracking performance.
The present invention was developed in light of the unmet need in the art.